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fecal microbiota transplant (Policlinico Gemelli)
- Development stage
- Unknown
- Lead developer
- Policlinico Gemelli
- Modality
- Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
- Administration
- Rectal
01
Overview
This is an investigational fecal microbiota transplant (FMT) therapy being studied by Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome, Italy. The active ingredient is donor fecal microbiota obtained from healthy donors. It is classified as a biologic, microbiome-based therapeutic. The therapy is being investigated for the eradication of gut colonization by carbapenem-resistant Enterobacteriaceae (CRE). The mechanism of action is to restore a healthy and diverse gut microbial community to re-establish colonization resistance against pathogenic bacteria. A randomized, double-blind, placebo-controlled study (NCT04759001) is underway to compare donor FMT against a placebo FMT in adult carriers of CRE. [13] There is no brand name for this investigational therapy.
- Other names
- donor fecal microbiota transplant-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-carbapenem-resistant enterobacteriaceae colonizationFMT
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